CN2421649Y - Special chromatographic column for testing polymer impurity content in medicine - Google Patents
Special chromatographic column for testing polymer impurity content in medicine Download PDFInfo
- Publication number
- CN2421649Y CN2421649Y CN 00214544 CN00214544U CN2421649Y CN 2421649 Y CN2421649 Y CN 2421649Y CN 00214544 CN00214544 CN 00214544 CN 00214544 U CN00214544 U CN 00214544U CN 2421649 Y CN2421649 Y CN 2421649Y
- Authority
- CN
- China
- Prior art keywords
- chromatographic column
- web member
- medicine
- inner chamber
- post housing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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- Treatment Of Liquids With Adsorbents In General (AREA)
Abstract
The utility model is composed of a joint, a gask-o-seal, a stainless steel filter sheet, a connecting piece, a stainless steel sieve, a filter sheet and a column shell. Because of the added connecting piece, the column shell can be directly connected with a high-performance liquid chromatograph. The column shell made of a stainless steel tube with good tightness can bear definite pressure, can be directly connected with the high-performance liquid chromatograph, can cause a polymer impurity content in measured medicine to have good reproducibility, obviously reduce relative errors, and remarkably shorten balancing time and sample parsing time of a chromatograph system. The chromatographic column with convenient loading can be used for measuring a polymer impurity content in the medicine.
Description
The utility model belongs to the auxiliary equipment of analytical instrument, particularly be the chromatographic column specially that is used for directly being connected mensuration medicine polymeric impurities content with high performance liquid chromatograph.
The method of measuring polymeric impurities content at present is Chinese Pharmacopoeia newly-increased assay method of version in 2000, this method regulation is used column chromatography and glass column, but this assay method poor reproducibility, chromatogram system equilibration time and sample analysis time are long, glass column filling, dismounting inconvenience, frangible, system sealing is bad, and can not directly be connected with high performance liquid chromatograph, test precision is low.
The purpose of this utility model provides a kind of can directly be connected with high performance liquid chromatograph, measures accurately, precision is high, the chromatographic column specially of polymeric impurities content in the mensuration medicine of favorable reproducibility
The purpose of utility model is achieved in that accompanying drawings is as follows:
A kind of chromatographic column specially of measuring polymeric impurities content in the medicine, it comprises joint, post housing, its design feature is:
1. chromatographic column is made up of joint 1, web member 5, post housing 11;
2. web member 5 front ends are provided with external thread, are connected with the inner chamber spiral of joint 1 rear end, and web member 5 rear ends are provided with tapped inner chamber, and the external thread of post housing 11 front ends is connected with the internal thread spiral of web member 5 rear end inner chambers;
3. be aligned in sequence with Gask-O-Seal 6, filter disc 8, Gask-O-Seal 10 between the inwall of web member 5 rear end inner chambers and post housing 11 front ends; Be provided with axial hole 13 in the web member 5.
Accompanying drawing 1 is for measuring the chromatographic column specially structural representation of polymeric impurities content in the medicine
Description of drawings and embodiment:
Can find out that by accompanying drawing 1 the utility model chromatographic column is is the center main part with post housing 11, its left and right sides two-end structure symmetry is identical, and post housing 11 two ends are connected with web member 5 and web member 5-1 respectively, are connected with joint 1 and 1-1 respectively through web member 5 and 5-1 again; Being connected to example with the left end of post housing 11 below is described as follows: post housing 11 left end screw threads are screwed in the inner chamber of web member 5 right-hand members, and the left end spiral of web member 5 is screwed in the inner chamber of joint 1 right-hand member; Be provided with Gask-O-Seal 6, stainless steel mesh 7, filter disc 8, stainless steel mesh 9, Gask-O-Seal 10 between the interior cavity wall of post housing 11 left ends and web member 5 from left to right successively; Be respectively equipped with Gask-O-Seal 2, stainless steel filter disc 3, Gask-O-Seal 4 from left to right between the cavity wall in the left end of web member 5 and the joint 1; Be provided with axial hole 12 in the joint 1, web member 5 is provided with axial hole 13, and the axial hole 14 of post housing 11 all is connected with axial hole 12,13 and axial hole 13-1,12-1; The joint 1 of left end is respectively equipped with screw thread 15 and 15-1 with the axial hole 12 of the joint 1-1 of right-hand member, the sidewall among the 12-1, is specifically designed to high performance liquid chromatograph to be connected.
Integral installation brief introduction before the utility model uses: at first Gask-O-Seal 6, stainless steel mesh 7, filter disc 8, stainless steel mesh 9, Gask-O-Seal 10 are put into successively the right-hand member inner chamber of web member 5, the left end with post housing 11 is screwed in the inner chamber of web member 5 again; Post housing 11 is stood vertically, from post housing 11 right-hand members (upper end after promptly erecting) with the wet-filling method filling agent of packing into; Gask-O-Seal 6-1, stainless steel mesh 7-1, filter disc 8-1, stainless steel mesh 9-1, Gask-O-Seal 10-1 are put into the inner chamber of web member 5-1 successively, and its inner chamber is torqued-up to the upper end of post housing 11; Put into Gask-O-Seal 2, stainless steel filter disc 3, Gask-O-Seal 4 successively in joint 1 left end inner chamber, the left end with web member 5 is screwed in the inner chamber of joint 1 again; In the inner chamber of joint 1-1, put into Gask-O-Seal 2-1, stainless steel filter disc 3-1, Gask-O-Seal 4-1 successively, and its inner chamber is torqued-up on the right-hand member of web member 5-1; At last joint 1 and 1-1 are connected respectively to the detecting device inlet and the pump discharge of high performance liquid chromatograph, can begin to have done test job.Above-mentioned filter disc 8 and 8-1 can be filter fast such as filter paper, pottery, sintered glass.
Test job is exemplified below: this chromatographic column is packed into and chromatographic column is connected with high performance liquid chromatograph behind the filling agent sephadex, and mobile phase A is 0.01ml/L phosphate buffer (PH7.0), and Mobile phase B is 0.01% sodium dodecyl sulfate solution.The beginning flow velocity is 1.0ml/min, treat that polymkeric substance goes out the peak and finishes after, adjust flow velocity, the medicine main peak is flowed out.The detection wavelength is 254nm.With the mobile phase A is moving phase, 2000 aqueous solution sample introduction 200ul measure with the 1mg/ml blue dextran, number of theoretical plate calculates with blue dextran 2000 peaks should be not less than 700, tailing factor should be between 0.75-1.5, with the Mobile phase B is moving phase, get reference substance solution, sample introduction 200ul repeatedly, the relative standard deviation of peak area value should be less than 2%.
The preparation of reference substance solution: get cefoperazone reference substance 25mg, put in the 250ml measuring bottle, be dissolved in water and be diluted to scale, shake up.
The preparation of need testing solution and mensuration: get test sample 500mg, put in the 25ml measuring bottle, add the mobile phase A dissolving and be diluted to scale, shaking up, get the 200ul injecting chromatograph immediately, is that moving phase is measured with the mobile phase A, the record chromatogram, other gets reference substance solution 200ul injecting chromatograph, is moving phase with the Mobile phase B, the record chromatogram.By the content of external standard method with calculated by peak area cefoperazone sodium polymer.
Advantage of the present utility model is a lot, is connected with high performance liquid chromatograph by this chromatographic column specially, can Tolerate certain pressure, make the favorable reproducibility of measuring pharmaceutical polymer content, relative error obviously reduces, look Spectrum system equilibration time and sample analysis time significantly shorten, and this chromatographic column is economical and practical, and is easy to use, can To be widely used in the mensuration of polymeric impurities content in the medicine.
Claims (5)
1. chromatographic column specially of measuring polymeric impurities content in the medicine, it comprises joint, post housing, it is characterized in that:
1. chromatographic column is made up of joint (1), web member (5), post housing (11);
2. web member (5) front end is provided with external thread, is connected with the inner chamber spiral of joint (1) rear end, and web member 5 rear ends are provided with tapped inner chamber, and the external thread of post housing (11) front end is connected with the internal thread spiral of web member (5) rear end inner chamber;
3. be aligned in sequence with Gask-O-Seal (6), filter disc (8), Gask-O-Seal (10) between the inwall of web member (5) rear end inner chamber and post housing (11) front end; Be provided with axial hole (13) in the web member (5).
2. the chromatographic column specially of polymeric impurities content in the mensuration medicine according to claim 1 is characterized in that: post housing (11) is made best of stainless-steel tube.
3. the chromatographic column specially of polymeric impurities content in the mensuration medicine according to claim 1 is characterized in that: add a stainless steel mesh (7), (9) respectively in filter disc (8) both sides.
4. the chromatographic column specially of polymeric impurities content in the mensuration medicine of stating according to claim 3, it is characterized in that: filter disc (8) is a filter paper.
5. the chromatographic column specially of polymeric impurities content in the mensuration medicine of stating according to claim 3, it is characterized in that: filter disc (8) is ceramic filtering plate or sintered glass filter disc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00214544 CN2421649Y (en) | 2000-05-10 | 2000-05-10 | Special chromatographic column for testing polymer impurity content in medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00214544 CN2421649Y (en) | 2000-05-10 | 2000-05-10 | Special chromatographic column for testing polymer impurity content in medicine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN2421649Y true CN2421649Y (en) | 2001-02-28 |
Family
ID=33580631
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 00214544 Expired - Fee Related CN2421649Y (en) | 2000-05-10 | 2000-05-10 | Special chromatographic column for testing polymer impurity content in medicine |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN2421649Y (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102507810A (en) * | 2011-10-12 | 2012-06-20 | 中国科学院南京土壤研究所 | Chromatographic separation column used under negative pressure condition |
| CN104020237A (en) * | 2014-06-24 | 2014-09-03 | 武汉矽感科技有限公司 | Improved FastGC column device capable of combination with ion mobility spectrometer |
-
2000
- 2000-05-10 CN CN 00214544 patent/CN2421649Y/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102507810A (en) * | 2011-10-12 | 2012-06-20 | 中国科学院南京土壤研究所 | Chromatographic separation column used under negative pressure condition |
| CN102507810B (en) * | 2011-10-12 | 2013-12-11 | 中国科学院南京土壤研究所 | Chromatographic separation column used under negative pressure condition |
| CN104020237A (en) * | 2014-06-24 | 2014-09-03 | 武汉矽感科技有限公司 | Improved FastGC column device capable of combination with ion mobility spectrometer |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C19 | Lapse of patent right due to non-payment of the annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |